K-number	K943313
Device name	PHENYTOIN FPIA REAGENT SET AND CALIBRATORS
Applicant	Sigma Diagnostics, Inc.
Product code	LGR
Device class	Class II
Decision date	Oct 27, 1994
Decision	Substantially Equivalent
Regulation	862.3350

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View the full FDA submission: accessdata.fda.gov

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PHENYTOIN FPIA REAGENT SET AND CALIBRATORS

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